NCT04028687 MDR - PMCF Study for Taperloc Complete Stems
| NCT ID | NCT04028687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Hip Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 820 participants |
| Start Date | 2020-02-13 |
| Primary Completion | 2032-02-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 820 participants in total. It began in 2020-02-13 with a primary completion date of 2032-02-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.
Eligibility Criteria
Inclusion Criteria: * Patient must be 18 years of age or older and skeletally mature * Patient must be willing and able to sign IRB approved informed consent * Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Exclusion Criteria: * Off-label use * Infection * Sepsis * Osteomyelitis * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * Osteoporosis * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy, or neuromuscular disease * Patient is known to be pregnant or nursing * Patient is a prisoner * Patient is a known alcohol or drug abuser * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04028687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04028687 currently recruiting?
Yes, NCT04028687 is actively recruiting participants. Contact the research team at megan.mckinnie@zimmerbiomet.com for enrollment information.
Where is the NCT04028687 trial being conducted?
This trial is being conducted at Henderson, United States, Plano, United States, Bellevue, United States.
Who is sponsoring the NCT04028687 clinical trial?
NCT04028687 is sponsored by Zimmer Biomet. The trial plans to enroll 820 participants.